MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Pain (1994); Peritonitis (2252)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the serious adverse events of hyperkalemia (characterized by leg pain and weakness), as well as suspected peritonitis (characterized by cloudy peritoneal effluent fluid), which required hospitalization and antibiotic therapy.The pdrn reported the serious adverse events were unrelated to any fresenius device(s) and/or product(s) malfunction or deficiency.The patient¿s nephrologist believes the cause of the hyperkalemia was due to peritoneal membrane failure.Additionally, the cause of the suspected peritonitis remains unknown; however, the patient will continue utilizing the same liberty select cycler.Those individuals undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.Based on the information available, the liberty select cycler and liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there is no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or the manufacturers¿ specifications.Should additional information become available, the clinical investigation and file will be updated accordingly.

Event Description

On 6/mar/2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized on (b)(6) 2024 due to suspected peritonitis.No additional information was provided during intake.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was admitted on (b)(6) 2024 with complaints of leg pain and weakness.Further testing revealed the patient was experiencing ¿significant¿ hyperkalemia (value not provided), however it is unclear what, if any, medical intervention was provided.Per the patient¿s nephrologist, causality was attributed to peritoneal membrane failure.A peritoneal effluent fluid culture and cell count were collected on admission and despite the results being negative, the patient¿s peritoneal effluent fluid was cloudy.Therefore, the patient was initially treated with vancomycin and ceftazidime, however due to persistently cloudy peritoneal effluent fluid the patient¿s ceftazidime was discontinued and replaced with meropenem (route, frequency, dose not provided).The patient was diagnosed with suspected peritonitis and the antibiotic course will continue through (b)(6) 2024.As of (b)(6) 2024, the patient remained hospitalized and was scheduled to be discharged in the next few days.The patient has recovered from the serious adverse events and will resume utilizing the same liberty select cycler following discharge.Per the pdrn, the serious adverse events were not caused by a fresenius device(s) and/or product(s) malfunction or deficiency.

Event Description

On 6/mar/2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized on (b)(6) 2024 due to suspected peritonitis.No additional information was provided during intake.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was admitted on (b)(6) 2024 with complaints of leg pain and weakness.Further testing revealed the patient was experiencing ¿significant¿ hyperkalemia (value not provided), however it is unclear what, if any, medical intervention was provided.Per the patient¿s nephrologist, causality was attributed to peritoneal membrane failure.A peritoneal effluent fluid culture and cell count were collected on admission and despite the results being negative, the patient¿s peritoneal effluent fluid was cloudy.Therefore, the patient was initially treated with vancomycin and ceftazidime, however due to persistently cloudy peritoneal effluent fluid the patient¿s ceftazidime was discontinued and replaced with meropenem (route, frequency, dose not provided).The patient was diagnosed with suspected peritonitis and the antibiotic course will continue through (b)(6) 2024.As of (b)(6) 2024, the patient remained hospitalized and was scheduled to be discharged in the next few days.The patient has recovered from the serious adverse events and will resume utilizing the same liberty select cycler following discharge.Per the pdrn, the serious adverse events were not caused by a fresenius device(s) and/or product(s) malfunction or deficiency.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18904350
• MDR Text Key: 337669709
• Report Number: 0008030665-2024-00269
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTION; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 113 KG